Randomization of Patients: Patients who sign an Informed Consent Form (ICF), complete all screening evaluations, pre-randomization (qualification) evaluations, and meet all entry criteria, will be eligible for randomization, and enrollment into the study. Randomization should occur within 2 days prior to study drug administration. All patients will be randomized in a 1:1:1 fashion to 1 of 3 treatment groups in order to reduce selection bias. All randomization will be managed centrally, by the GCRC.